Unique ID issued by UMIN | UMIN000018630 |
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Receipt number | R000021536 |
Scientific Title | The feasibility study of pharmacokinetics and immune response of T-DM1 in metastatic/recurrent HER2-positive breast cancer |
Date of disclosure of the study information | 2015/08/15 |
Last modified on | 2018/08/12 09:10:49 |
The feasibility study of pharmacokinetics and immune response of T-DM1 in metastatic/recurrent HER2-positive breast cancer
The feasibility study of pharmacokinetics and immune response of T-DM1 in metastatic/recurrent HER2-positive breast cancer
The feasibility study of pharmacokinetics and immune response of T-DM1 in metastatic/recurrent HER2-positive breast cancer
The feasibility study of pharmacokinetics and immune response of T-DM1 in metastatic/recurrent HER2-positive breast cancer
Japan |
Breast Cancer
Hematology and clinical oncology | Breast surgery |
Malignancy
NO
To validate a new technique to measure pharmacokinetics and immune response in breast cancer patients treated with T-DM1.
PK,PD
Exploratory
Pharmacokinetics and immune response of T-DM1
Observational
20 | years-old | <= |
Not applicable |
Male and Female
a) Pathologically confirmed breast cancer
b) HER2-positive by IHC or ISH
c) Locally advanced or metastatic/recurrent breast cancer
d) Any prior treatment
e) 20 y.o. and over
f) ECOG performance status 0-2
g) Adequate interval from prior therapy
h) Interval over 2w from prior radiotherapy
i) Adequate baseline organ and marrow function as defined below:
Platelet count >= 100,000mm3
Hemoglobin >= 7.0g/dL
AST and ALT <= 2.5x ULN
Serum bilirubin <= 1.5 x ULN
j) Baseline left ventricular ejection fraction (LVEF) >= 50% by echocardiography
k) Signed written informed consent
a) Brain metastasis with clinical symptoms
b) Uncontrollable body fluid
c) Concurrent serious disease or condition
Active infection
concurrent serious psychiatric disorder
Ileus, breeding
Uncontrollable angina and mycardial infarction within 3 months, severe heart disease with heart failure
d) pregnant or lactating women
e) Patient considered irrelevant by attending physician for the study
20
1st name | |
Middle name | |
Last name | Kenji Tamura |
National Cancer Center Hospital
Breast and Medical Oncology
5-1-1 Tsukiji, Chuo-ku, Tokyo
03-3542-2511
ketamura@ncc.go.jp
1st name | |
Middle name | |
Last name | Akihiko Shimomura |
National Cancer Center Hospital
Breast and Medical Oncology
5-1-1 Tsukiji, Chuo-ku, Tokyo
03-3542-2511
ashimomu@ncc.go.jp
National Cancer Center Hospital
Japan Agency for Medical Research and Development
Japanese Governmental office
NO
2015 | Year | 08 | Month | 15 | Day |
Partially published
Main results already published
2015 | Year | 03 | Month | 31 | Day |
2015 | Year | 04 | Month | 01 | Day |
One year follow-up after completion of recruitment.
2015 | Year | 08 | Month | 10 | Day |
2018 | Year | 08 | Month | 12 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021536
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